Monitoring the safety of COVID-19 vaccines

Swissmedic requires everyone involved in the vaccination campaign and other healthcare professionals to assist directly with the monitoring of the vaccines so that any safety problems can be detected promptly and corresponding countermeasures taken.

The vaccination campaign that is due to begin shortly in Switzerland is designed to slow the further spread of COVID-19 in the population and thus reduce the number of serious and fatal cases of this disease. The vaccines used in the campaign differ significantly, in terms both of their structure and their modes of action, from most other vaccines used to prevent illnesses such as measles, hepatitis B or influenza.

Vaccines have to undergo extensive testing with several thousands of volunteers before they are authorised by Swissmedic for subsequent administration. This authorisation process results in safe, effective and high-quality vaccines. But despite every precaution, side effects – particularly those that are very rare or that occur in certain patient groups – cannot always be reliably detected before authorisation. Therefore, the safety of vaccines continues to be constantly monitored even after they have been introduced. This applies to COVID-19 vaccines just as it does to any other newly authorised medicines. The special feature of the current situation is that the new vaccines will be administered to very large numbers of people over a very short period during the vaccination campaign. Moreover, a substantial proportion of these vaccine recipients are burdened with pre-existing illnesses that may favour the occurrence of side effects.

Advice for healthcare professionals

Please report to Swissmedic promptly if you notice any side effects, or suspected side effects, of the COVID-19 vaccines. This applies especially to serious or previously unknown adverse effects which, according to Article 59 of the Therapeutic Products Act, are subject to a statutory reporting obligation.

You should use the online tool ElViS (Electronic Vigilance reporting System) for this purpose. A one-time registration is required before the first use of the tool. This only takes a few minutes and involves two codes that will be sent to you by e-mail or as a text message. You will then be able to record reports and, after entering the required medical details, send them at the touch of a button. Additional documentation, e.g. laboratory reports or hospital discharge reports, can easily be sent electronically as attachments. ElViS guarantees the secure transmission of sensitive medical data and facilitates the prompt assessment of reports by Swissmedic and the regional pharmacovigilance centres. Swissmedic advises all healthcare professionals to register now for ElViS:

Advice for vaccinated individuals / patients

If you notice any signs or symptoms that could be side effects, you should first contact either the site where you were vaccinated or your own doctor. Your doctor has the necessary specialist information about the vaccine and can decide, after an initial examination, whether a side effect is involved or whether your symptoms are more likely to be caused by something else – and can then also take any action that is required.